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The efficacy of convalescent plasma for coronavirus disease 2019 (COVID-19) is unclear. Although most randomized controlled trials have shown negative results, uncontrolled studies have suggested that the antibody content could influence patient outcomes. We conducted an open-label, randomized controlled trial of convalescent plasma for adults with COVID-19 receiving oxygen within 12 d of respiratory symptom onset (NCT04348656). Patients were allocated 2:1 to 500 ml of convalescent plasma or standard of care. The composite primary outcome was intubation or death by 30 d. Exploratory analyses of the effect of convalescent plasma antibodies on the primary outcome was assessed by logistic regression. The trial was terminated at 78% of planned enrollment after meeting stopping criteria for futility. In total, 940 patients were randomized, and 921 patients were included in the intention-to-treat analysis. Intubation or death occurred in 199/614 (32.4%) patients in the convalescent plasma arm and 86/307 (28.0%) patients in the standard of care arm—relative risk (RR) = 1.16 (95% confidence interval (CI) 0.94–1.43, P = 0.18). Patients in the convalescent plasma arm had more serious adverse events (33.4% versus 26.4%; RR = 1.27, 95% CI 1.02–1.57, P = 0.034). The antibody content significantly modulated the therapeutic effect of convalescent plasma. In multivariate analysis, each standardized log increase in neutralization or antibody-dependent cellular cytotoxicity independently reduced the potential harmful effect of plasma (odds ratio (OR) = 0.74, 95% CI 0.57–0.95 and OR = 0.66, 95% CI 0.50–0.87, respectively), whereas IgG against the full transmembrane spike protein increased it (OR = 1.53, 95% CI 1.14–2.05). Convalescent plasma did not reduce the risk of intubation or death at 30 d in hospitalized patients with COVID-19. Transfusion of convalescent plasma with unfavorable antibody profiles could be associated with worse clinical outcomes compared to standard care., A randomized trial in patients hospitalized with COVID-19 showed no benefit and potentially increased harm associated with the use of convalescent plasma, with subgroup analyses suggesting that the antibody profile in donor plasma is critical in determining clinical outcomes.

ObjectivesTo identify patient-generated priority topics for future primary care research in British Columbia (BC), Canada within a diverse patient population.DesignMixed-methods priority setting exercises framed by the dialogue model, using the nominal group technique (rank-ordered scoring) and province-wide online surveys capturing importance ratings of the top 10 primary healthcare topics from patients and primary care providers.SettingBC, Canada.ParticipantsTopic identification was completed by 10 patient partners (7 female, 3 male) from the BC Primary Health Care Research Network Patient Advisory; online surveys were completed by 464 patients and 173 primary care providers.ResultsThe 10 members recruited to the patient advisory provided over 80 experiences of what stood out for them in BC primary care, which were grouped thematically into 18 topics, 10 of which were retained in province-wide surveys. Top-rated survey topics for both patients (n=464) and providers (n=173) included being unable to find a regular family doctor/other primary healthcare provider, support for living with chronic conditions, mental health resources and information sharing, including electronic medical records. However, all 10 topics were rated important, on average, by both groups.ConclusionsThe current project activities demonstrate the feasibility of including patients in priority setting exercises for primary healthcare in general, rather than focusing on a condition-specific population or disease area. There was considerable overlap between patient-generated topics and topics previously identified by other stakeholders, but patients identified two additional topics (mental health resources, improve and strengthen patient–provider communication). More similarities than differences in topic importance between patients and providers emerged in the online surveys. The project activities that follow (rapid literature reviews, multistakeholder dialogue) will highlight under-researched topics and inform the development of specific research questions.